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FDA 510(k)

Edison System

K-Number: K233466 · 2024-03-13

ApplicantHistoSonics, Inc.
Decision Date2024-03-13
Product CodeQGM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Edison System is a medical device manufactured by HistoSonics, Inc.. It received FDA 510(k) clearance on 2024-03-13 under approval number K233466. The device is classified under product code QGM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Edison System?

Edison System is a medical device that received FDA 510(k) clearance on 2024-03-13. It is manufactured by HistoSonics, Inc.. The 510(k) number is K233466.

When was Edison System approved by the FDA?

Edison System received FDA 510(k) clearance on 2024-03-13, under approval number K233466.

What company makes Edison System?

Edison System is manufactured by HistoSonics, Inc..

What is the FDA product code for Edison System?

The FDA product code for Edison System is QGM.

Related Clinical Trials

NCT06486454 Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study) RECRUITING NCT07214675 The Edison System for Treatment of Benign Prostatic Hyperplasia (BPH) Using Histotripsy RECRUITING

Other Devices by HistoSonics, Inc.

DEN220087Edison System K241902Edison System

Related Devices (Code: QGM)

DEN220087Edison SystemHistoSonics, Inc. K241902Edison SystemHistoSonics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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